Scheduling of two projects changed; optimization of the clinical development path for Burprenorphine Monthly Depot in Europe only, and an additional Phase 2 trial for Buprenorphine Hemiadipate Oral Swallowable Tablet, will likely result in some delay to previous estimated approval in 2018 for both projects, new dates to be confirmed in 2016.

ANDA Litigation. Trial in the lawuits against Actavis and Par commenced today November 3rd. There are now six ANDA filers seeking FDA approval to market generic Suboxone Film in the US.

Outlook

Full year 2015 guidance today raised to net revenue of $990m-$1,010m (previously $935m-$965m) and net income of $215m-$225m (previously $185m to $210m) at actual exchange rate.

The guidance assumes current market conditions in the US continue through the remainder of 2015. The guidance also reflects some increase in investment in R&D and prelaunch activity for Nasal Naloxone and Buprenorphine Monthly Depot in the context of operating expenses which are in any case proportionally higher in H2.

Comment by Shaun Thaxter, CEO of Indivior PLC

“Our performance this year to date continues to run well ahead of our plan, which anticipated a more challenging market environment beginning in the second quarter“ commented Shaun Thaxter, CEO of Indivior PLC. “As we see no imminent change in conditions, we can raise our guidance for the full year. This over-delivery against our plan allows us both to reward shareholders with higher than expected profits, while using a proportion of the over-delivery to reinvest in the long-term organic growth drivers of our business. Accordingly we are consciously stepping up our investment in R&D projects, and particularly in pre-launch marketing and market preparation for the imminent launch of Nasal Naloxone and in preparation for the launch of our Monthly Depot of Buprenorphine. We look forward to giving more insight into these investments at our R&D Day for investors on December 9th. At the same time, we will give some additional insight into the impact of these investments on the financial outlook for 2016.“

“Indivior PLC is focused on empowering patients and striving to improve their quality of life by pioneering innovative, high-quality, accessible and cost effective treatments,“ Shaun Thaxter continued. “I am delighted with our progress towards realizing our vision and achieving key strategic priorities for 2015; Suboxone Film share of 59% in the US is slightly ahead of the exit share for 2014 and reinforces our confidence in the sustainability of Suboxone Film; the treatment market has grown in the US, with many new doctors certified. Our transformational pipeline of potential treatments for addiction is moving forward steadily with our opioid overdose rescue medication granted priority review by the FDA for anticipated approval before the end of this year, our monthly depot of Buprenorphine (RBP-6000) in Phase 3 trials, while our oral swallowable tablet of Buprenorphine Hemiadipate has just started its first clinical trial in man in September; our first clinical trial for Arbaclofen Placarbil for alcohol use disorders commenced in September while positive clinical efficacy and safety data from our Phase 3 trial of RBP-7000, the monthly risperidone depot, was published in May. Our belief in the growing medium-term opportunity for Indivior PLC continues to be justified.“